Neonatal HyperbilirubinemiaEarly Phase 1MDTinsNHNCT06832800
Modified Diagnosis and Treatment of Neonatal Hemolysis With ETCOc in sNH
A Early Phase 1 study testing MDT in people with Neonatal Hyperbilirubinemia, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if modified diagnosis and treatment (MDT) of neonatal hemolysis (a common cause to newborn jaundice) incorporated with ETCOc measurement (a non-invasive measurement of exhaled gas) works to prevent brain damage in newborns with severe hyperbilirubinemia (sNH). Read more about this study
- Who is it for?
- Ages 4 hours to 28 days
- Conditions the study is for
- Neonatal Hyperbilirubinemia
- What is being tested?
- MDT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2025to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 hours to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with gestational age of 35(+0) to 41(+6) weeks and birth weight ≥ 2500 grams
- Infants with severe neonatal hyperbilirubinemia, including those whose serum total
- bilirubin (TSB) levels reach above 20 mg/dL or whose TSB levels at any time reach within 2 mg/dL of the exchange transfusion threshold (i.e., TSB > (threshold - 2) mg/dL).
Who cannot join
- Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Women's Hospital School of Medicine Zhejiang University
Hangzhou
Yuqi Wang, 086-0571-87061501
About this study
Official title: Modified Diagnosis and Treatment of Neonatal Hemolysis Incorporated With ETCOc Measurement in Severe Neonatal Hyperbilirubinemia Management
The goal of this clinical trial is to learn if modified diagnosis and treatment (MDT) of neonatal hemolysis (a common cause to newborn jaundice) incorporated with ETCOc measurement (a non-invasive measurement of exhaled gas) works to prevent brain damage in newborns with severe hyperbilirubinemia (sNH). It will also learn about the. occurrence of cranial MRI in the study participants. The main questions it aims to answer are:
- Does MDT lower the possibilities participants have brain damage before the age of one?
- How many times of abnormalities in cranial MRI is detected before the age of one? Researchers will compare MDT to a control (a current management) to see if MDT works to prevent brain damage in newborns with sHN.
Read more
Participants will:
- Take MDT or a control method in the management of sNH
- Assess if there's brain damage before discharge and at the year of one
- Record how many times of abnormalities in cranial MRI is detected before the age of one
- Conditions
- Neonatal Hyperbilirubinemia
- Being tested
- MDT, control (current management)
- Keywords
- ETCOc, neonatal hemolysis, neonatal hyperbilirubinemia, modified
- Medical subject headings
- Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDTCombination product
（actually not combination product, but have to select that option in order to delete warning in "study desine"）MDT method for sNH with the description as follow： 1. diagnosis of neonatal hemolysis：
The neonatal subjects with symptom of hyperbilirubinemia are diagnosed as hemolysis if they met one criterion from Category A or two criteria from Category B:
Category A:
- Positive DAT
- Significantly elevated ETCOc;
- Significant morphological abnormalities
Category B:
- Positive release test;
- Elevated ETCOc;
- COHb > 1.2%;
- Hb < 140 g/L or Hct) < 40%;
- Ret > 6%. 2.Exchange transfusion (ET) therapy for sNH： any of the following criteria are met: (1) TSB ≥ the current ET threshold; (2) TSB > (ET - 2) mg/dL or the increase of TSB > 0.5 mg/dL/h, accompanied by abnormal aEEG findings; (3) TSB > (ET - 2) mg/dL or > 0.5 mg/dL/h, accompanied by a BIND score of 4-6; (4) Presence of clinical manifestations of acute ABE; (5) BIND score of 7-9.
control (current management)Other
Control (current) method for sNH (severe neonatal hemolysis) with the description as follow：
- Diagnosis of neonatal hemolysis： The neonatal subjects with symptom of hyperbilirubinemia are diagnosed as hemolysis if they have positive Direct Antiglobulin Test (DAT) or positive release test result.
- Exchange transfusion (ET) therapy for sNH： The neonatal subjects with symptom of hyperbilirubinemia are treated with ET therapy if their Total serum bilirubin (TSB) reaches or exceeds the current exchange transfusion threshold;
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | modified diagnosis and treatment (MDT) for neonatal hemolysis Receives: Combination Product: MDT |
| control | Other | Control (current) method for sNH (severe neonatal hemolysis) with the description as follow：
1. Diagnosis of neonatal hemolysis： The neonatal subjects with symptom of hyperbilirubinemia are diagnosed as hemolysis if they have positive Direct Antiglobulin Test (DAT) or positive release test result.
2. Exchange transfusion (ET) therapy for sNH： The neonatal subjects with symptom of hyperbilirubinemia are treated with ET therapy if their Total serum bilirubin (TSB) reaches or exceeds the current exchange transfusion threshold; Receives: Other: control (current management) |
What is being measured
The primary outcome is the main question the study is designed to answer.
neural damage confirmed by professional assessments such as Bayley Scales
Neurological impairment, including any of the following: diagnosis of cerebral palsy, diagnostic hearing tests indicating hearing impairment, or a score lower than 85 on the Bayley Scales Neurobehavioral Assessment. Bayley Scales means Bayley Scales of Infant and Toddler Development and it can assess the neural development of infants including Cognitive, Language (Receptive/Expressive), Motor (Fine/Gross), Social-Emotional, and Adaptive Behavior. Standard scores for each domain range from 40 to 160 (mean = 100; SD = 15). Higher scores indicate better developmental outcomes, while lower scores suggest potential delays.
For example, a cognitive score of 115 reflects performance above the average range, whereas a score of 85 falls below the average range.
Measured: at the age of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start21 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HyperbilirubinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingying Bao, Doctor, Principal investigator, Women's Hospital, Zhejiang University School of MedicineBao, Doctor, Principal investigator, Women's Hospital, Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832800
- Sponsor's protocol ID
- PRO2024-737
- Other IDs
- 2025KY929
- Acronym
- MDTinsNH
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Diagnosis and Treatment of Neonatal Hemolysis Incorporated With ETCOc Measurement in Severe Neonatal Hyperbilirubinemia Management
- ClinicalTrials.gov ID
- NCT06832800
- Acronym / sponsor ID
- MDTinsNH / PRO2024-737
- Conditions
- Neonatal Hyperbilirubinemia
- Keywords
- ETCOc, neonatal hemolysis, neonatal hyperbilirubinemia, modified
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if modified diagnosis and treatment (MDT) of neonatal hemolysis (a common cause to newborn jaundice) incorporated with ETCOc measurement (a non-invasive measurement of exhaled gas) works to prevent brain damage in newborns with severe hyperbilirubinemia (sNH). It will also learn about the. occurrence of cranial MRI in the study participants. The main questions it aims to answer are:
- Does MDT lower the possibilities participants have brain damage before the age of one?
- How many times of abnormalities in cranial MRI is detected before the age of one? Researchers will compare MDT to a control (a current management) to see if MDT works to prevent brain damage in newborns with sHN.
Participants will:
- Take MDT or a control method in the management of sNH
- Assess if there's brain damage before discharge and at the year of one
- Record how many times of abnormalities in cranial MRI is detected before the age of one
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Combination Product: MDTmodified diagnosis and treatment (MDT) for neonatal hemolysis |
| control | Other | Other: control (current management)Control (current) method for sNH (severe neonatal hemolysis) with the description as follow： 1. Diagnosis of neonatal hemolysis： The neonatal subjects with symptom of hyperbilirubinemia are diagnosed as hemolysis if they have positive Direct Antiglobulin Test (DAT) or positive release test result. 2. Exchange transfusion (ET) therapy for sNH： The neonatal subjects with symptom of hyperbilirubinemia are treated with ET therapy if their Total serum bilirubin (TSB) reaches or exceeds the current exchange transfusion threshold; |
Who may qualify
- Ages
- 4 hours to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants with gestational age of 35(+0) to 41(+6) weeks and birth weight ≥ 2500 grams
- Infants with severe neonatal hyperbilirubinemia, including those whose serum total
- bilirubin (TSB) levels reach above 20 mg/dL or whose TSB levels at any time reach within 2 mg/dL of the exchange transfusion threshold (i.e., TSB > (threshold - 2) mg/dL).
Key exclusion criteria (1 listed)
- Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDT（actually not combination product, but have to select that option in order to delete warning in "study desine"）MDT method for sNH with the description as follow： 1. diagnosis of neonatal hemolysis： The neonatal subjects with symptom of hyperbilirubinemia are diagnosed as hemolysis if they met one criterion from Category A or two criteria from Category B: Category A: 1. Positive DAT 2. Significantly elevated ETCOc; 3. Significant morphological abnormalities Category B: 1. Positive release test; 2. Elevated ETCOc; 3. COHb > 1.2%; 4. Hb < 140 g/L or Hct) < 40%; 5. Ret > 6%. 2.Exchange transfusion (ET) therapy for sNH： any of the following criteria are met: (1) TSB ≥ the current ET threshold; (2) TSB > (ET - 2) mg/dL or the increase of TSB > 0.5 mg/dL/h, accompanied by abnormal aEEG findings; (3) TSB > (ET - 2) mg/dL or > 0.5 mg/dL/h, accompanied by a BIND score of 4-6; (4) Presence of clinical manifestations of acute ABE; (5) BIND score of 7-9. | Combination product | study |
| control (current management)Control (current) method for sNH (severe neonatal hemolysis) with the description as follow： 1. Diagnosis of neonatal hemolysis： The neonatal subjects with symptom of hyperbilirubinemia are diagnosed as hemolysis if they have positive Direct Antiglobulin Test (DAT) or positive release test result. 2. Exchange transfusion (ET) therapy for sNH： The neonatal subjects with symptom of hyperbilirubinemia are treated with ET therapy if their Total serum bilirubin (TSB) reaches or exceeds the current exchange transfusion threshold; | Other | control |
Primary outcome
neural damage confirmed by professional assessments such as Bayley Scales
Time frame: at the age of 12 months
Neurological impairment, including any of the following: diagnosis of cerebral palsy, diagnostic hearing tests indicating hearing impairment, or a score lower than 85 on the Bayley Scales Neurobehavioral Assessment. Bayley Scales means Bayley Scales of Infant and Toddler Development and it can assess the neural development of infants including Cognitive, Language (Receptive/Expressive), Motor (Fine/Gross), Social-Emotional, and Adaptive Behavior. Standard scores for each domain range from 40 to 160 (mean = 100; SD = 15). Higher scores indicate better developmental outcomes, while lower scores suggest potential delays. For example, a cognitive score of 115 reflects performance above the average range, whereas a score of 85 falls below the average range.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Yes
Related trials for Neonatal Hyperbilirubinemia
Recruiting
Abdominal Massage for Newborn Jaundice
Neonatal Jaundice
Recruiting
Foot Reflexology and Massage in Neonates Receiving Phototherapy
Neonatal Hyperbilirubinemia
Active, not recruiting
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
Prematurity, Low Birth Weight
Active, not recruiting
Newborn Abdominal Massage to Prevent Hyperbilirubinemia
Newborn Jaundice
Not yet recruiting
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Indirect Hyperbilirubinemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yingying Bao, Doctor principal investigator
Women's Hospital, Zhejiang University School of Medicine
Bao, Doctor principal investigator
Women's Hospital, Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MDT in people with Neonatal Hyperbilirubinemia, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YIngying B (086-13777834165, yingyingbao@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neural damage confirmed by professional assessments such as Bayley Scales (time frame: at the age of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.